On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept). This approval makes Celltrion the sixth company to receive FDA approval for an aflibercept biosimilar, joining Biocon, Samsung Bioepis, Formycon, Sandoz, and Amgen.
Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (“VEGF-A”) and placental growth factor (“PlGF”), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (“nAMD”), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.
Regeneron’s BPCIA aflibercept litigation against Celltrion remains pending. As we previously reported, it is anticipated that Celltrion will file a motion to dissolve the preliminary injunction entered by the Court, with its opening brief due on October 31, 2025.